Testing different methods for setting ventilator support in ICU patients

A Pragmatic Pilot Trial Evaluating Inspiratory Pressure Adjustment Based on Pressure Muscle Index in Patients Undergoing Pressure Support Ventilation

This study is testing two different ways to set up breathing support for ICU patients with severe breathing problems to see which one works better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06769360 on ClinicalTrials.gov

What this trial studies

This pilot trial aims to compare two strategies for setting pressure support ventilation (PSV) levels in mechanically ventilated patients with acute hypoxic respiratory failure. One strategy uses the traditional method based on tidal volume and respiratory rate, while the other utilizes the pressure muscle index to better match the patient's inspiratory effort. The study will be conducted in two ICU centers, with each method being tested for four weeks, separated by a washout period. The trial will also assess clinician adherence and explore clinical outcomes related to these ventilation strategies.

Who should consider this trial

Good fit: Ideal candidates include mechanically ventilated patients in the ICU with acute hypoxic respiratory failure who require ventilation for at least 24-48 hours.

Not a fit: Patients under 18 years old or those with certain exclusions such as neuromuscular diseases or moribund conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved ventilation strategies that enhance patient outcomes in critical care settings.

How similar studies have performed: While the comparative effectiveness of these two approaches is uncertain, previous studies have indicated that the pressure muscle index may provide a more accurate assessment of inspiratory effort, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. PSV initiated during the last 24 hours, whether transition from controlled modes or primary initiation;
2. Mechanical ventilation expected to be required for at least 24-48 hours by responsible physicians;
3. The partial pressure of oxygen in arterial blood (PaO2)/inspired oxygen fraction (FiO2) ≤ 300 mmHg (measuring at clinical FiO2 and positive end-expiratory pressure \[PEEP\]);
4. No sedation or stable sedation with Richmond Agitation Sedation Scale (RASS) of -2 to +1 or Riker's Sedation-Agitation Scale (SAS) of 3 to 4.

Exclusion Criteria:

1. Age younger than 18 years old;
2. Initiation of PSV before ICU admission;
3. Duration of mechanical ventilation longer than 7 days before enrollment;
4. History of neuromuscular diseases;
5. Clinical suspicion of increased intracranial pressure;
6. Presentation with pneumothorax and/or bronchopleural fistula;
7. Extracorporeal support;
8. Moribund conditions;
9. Refusal by the ICU physicians or the patient.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jian-Xin Zhou, MD — Beijing Shijitan Hospital, Capital Medical University
• Study coordinator: Jian-Xin Zhou, MD

Conditions Critical Care; Acute Hypoxic Respiratory Failure; Ventilator Lung; pressure support ventilation; pressure muscle index; inspiratory effort